Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization.
Camurus is a knowledge-based company, and the know-how, innovation, and expertise of our employees is an essential part of our continued success. Passion, knowledge, and creativity are vital for attaining our goal: to offer patients and society new and improved treatments for serious and chronic diseases. The vast majority of Camurus’ employees work in research and development and many of them hold advanced university degrees. Our business and comprehensive expertise are continually developed through an active transfer of knowledge throughout our international network and through intense collaborations with academia and industrial partners.
Our development create value across the pharmaceutical development cycle, from early programs to partnerships with international pharmaceutical companies. To maximize the value creation for our products, we are building our own European commercial organization with an initial focus on the opioid dependence market and other specialty markets with suitable dynamics and a concentrated prescriber base.
Camurus had a productive second quarter 2021 with increasing revenues, new regulatory approvals, progress in the development portfolio, and the publication of strong data in leading scientific journals. The company is in an expansive phase and has today about 150 employees, in addition, many consultants and contract companies are used. Camurus was founded 1991, has its HQ in Ideon Science Park in Lund and is listed on Nasdaq Stockholm.
For further information about Camurus, please visit the company's website http://www.camurus.com.
Clinical Trial Administrator
We are looking for an experienced Clinical Trial Administrator (CTA), to provide administrative support to the clinical project teams in accordance with ICH GCP, Camurus SOPs and local regulations.
You will be responsible for the ongoing handling and archiving of documents in clinical trials, in collaboration with the clinical trial team and the clinical CRO. You will have close collaborations with internal stakeholders, such as
Clinical Trial Managers, Regulatory Affairs, Legal and Quality, as well as external contacts with CROs, eTMF vendor and other development partners. To succeed in this role, we believe that you have excellent collaboration and communication skills, and both experience and interest in various IT systems for document management.
The company is in a very active phase, with several studies in phase III, as well as trials in earlier development phase, ongoing or under planning. Therefore, the company needs to strengthen the organisation with someone who takes responsibility for initiating, structuring, and managing the clinical documentation and provide oversight of the electronic Trial Master Files. It is an advantage if you are used to SharePoint or similar systems. This is a key role supporting the clinical teams at Camurus.
The role requires an organized, structured, and proactive approach as well as accuracy and flexibility. We are looking for someone who is creative, proactive and "service-minded". You are good at creating and maintaining good relationships with colleagues and partners as well as taking initiatives and has strong communication skills. The position puts high demands on being able to act independently but also to collaborate effectively both internally and externally.
The desire to learn new tasks and a positive view of change are also good characteristics, as Camurus is growing responsibly, where working methods and organization will change continuously to adapt to the business needs.
The position is located at the head office at Ideon in Lund, and you will report to the company's VP Clinical Development & Pharmacovigilance.
Main purpose of the job
Key responsibilities will include but not be limited to:
• Member of the clinical project team with the goal to contribute towards efficient management of clinical trials
• Monitoring of the Trial Master File (TMF)
• Preparing essential clinical trial documents
• Supporting ethics, regulatory and other submissions
• Maintaining internal tracking documents
• Tracking, distributing, and archiving documents and provide oversight of outsourced such activities
• Managing defined sub-tasks as needed and applicable, e.g., trial supplies coordination, contract review coordination etc
• Participate in writing and revising Standard Operating Procedures to further develop in-house processes
Experience and qualifications
• Post-secondary education or relevant experience in Life Science
• Previous clinical research experience in pharma/biotech of a CRO or Sponsor
• Experience from working with eTMF providers is an advantage
• Project management and administrative skills
• Good computer skills, including MS Office package
• Excellent oral and written communication skills in English
Required skills and personal characteristics
• A Team player who builds wide and effective networks of contacts inside and outside the organization
• Excellent communication skills, orally and written in English
• Demonstrates a rapid understanding of information, gathers comprehensive information, and encourages an organisational learning approach
• Focuses on customer satisfaction with a solution-oriented mindset, sets high standards for quality and quantity, structured and quality minded
• Flexible, adapts to changing circumstances and making positive use of the opportunities it presents
The position as Clinical Trial Administrator will be based in Lund with some flexibility to work from home.
Opportunities with the role
This position offers an experienced Clinical Trial Administrator an opportunity to join a well-funded company with a highly professional and enthusiastic team. Being part of a small organisation offers high visibility, broad responsibilities, and an opportunity to make a real impact.
You will have the opportunity to work in a small entrepreneurial pharmaceutical company with products that can make a big difference for patients with severe and chronic conditions.
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
M: +46 706 152 772
M: +46 701 725 379
Apply for the position at http://www.peaksearch.se